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Active Immunization of Patients With Stage III and IV Melanoma in Whom a Regional Lymph Node Dissection is Planned, With Peptide-Pulsed Dendritic Cells: Evaluation of in Vivo Immune and Clinical Response and Migration


Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Both
Melanoma Stage III or IV

Thank you

Trial Information

Active Immunization of Patients With Stage III and IV Melanoma in Whom a Regional Lymph Node Dissection is Planned, With Peptide-Pulsed Dendritic Cells: Evaluation of in Vivo Immune and Clinical Response and Migration

Inclusion Criteria


Inclusion criteria:

Histologically documented evidence of melanoma

Stage III-IV melanoma according to the 2001 AJCC criteria

Radical lymph node dissection planned, either with curative (stage III) or palliative
(stage IV) intent

Melanoma expressing gp100 (compulsory) and tyrosinase (non-compulsory)

HLA-A2.1 phenotype according to lymphocyte HLA typing

ECOG performance status 0-1, life expectancy > 3 months

Age 18-75 years

Interval since last prior chemotherapy, immunotherapy or radiotherapy at least 4 weeks, no
residual toxicity of prior treatment.

WBC > 3.0 x 109/l, lymphocytes > 0.8 x 109/l, platelets > 100 x 109/l, serum creatinine <
150 μmol/l, serum bilirubin < 25 μmol/l

Written informed consent

Expected adequacy of follow-up

Exclusion criteria:

No clinical signs of CNS metastases, in patients with a clinical suspicion of other
metastases diagnostic tests should be performed to exclude this.

No concomitant use of corticosteroids or other immunosuppressive agents

No history of second malignancy within the last 5 years. Adequately treated basal
carcinoma of skin or carcinoma in situ of cervix is acceptable within this period

No serious concomitant disease, no active infections. No autoimmune disease or organ
allografts, no clinical suspicion of HIV or Hepatitis B

No contra-indications for MRI-scanning: claustrophobia, pacemaker or pacemaker threads,
cerebral clips or artificial heartvalves, internal hearing prosthesis No known allergy to
shell fish (contains KLH)

No pregnant or lactating women

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Immune response

Outcome Time Frame:

during the first 10 years

Safety Issue:

No

Principal Investigator

Prof. C.J.A. Punt, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

2004-3126

NCT ID:

NCT00243594

Start Date:

September 1999

Completion Date:

Related Keywords:

  • Melanoma Stage III or IV
  • Dendritic cells
  • Immunotherapy
  • Vaccination
  • Melanoma
  • Peptides
  • MRI
  • Scintigraphy
  • Immune response
  • Melanoma

Name

Location